The following data is part of a premarket notification filed by Kronner Prototypes, Inc. with the FDA for Kronner Low Profile Scope Holder.
| Device ID | K000663 |
| 510k Number | K000663 |
| Device Name: | KRONNER LOW PROFILE SCOPE HOLDER |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | KRONNER PROTOTYPES, INC. 1443 UPPER CLEVELAND RAPIDS RD Roseburg, OR 97470 |
| Contact | Richard Kronner |
| Correspondent | Richard Kronner KRONNER PROTOTYPES, INC. 1443 UPPER CLEVELAND RAPIDS RD Roseburg, OR 97470 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-28 |
| Decision Date | 2000-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856589007011 | K000663 | 000 |